Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome

University of Florida30 enrolled

Overview

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our previous studies showed abnormal sensations of second pain (wind-up), indicating central hypersensitivity as an important mechanism of FM. Triggering events have been implicated as the cause of central hypersensitivity.

Increasing evidence has shown that the hypersensitivity of FM is not limited to painful stimuli but seems to extend to non-painful stimuli as well. These stimuli include smell, taste, touch, light, and sound. This study will provide detailed QST examinations of FM subjects and controls' responses to light using visually evoked potentials (VEP). In addition, careful characterization of experimental pain responding across multiple sensory modalities will be examined.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Fibromyalgia

Interventions

Paced Auditory Serial Addition task (PASAT)BEHAVIORAL

Single and double digits are presented at intervals between 2 and 3 seconds and the participant must add each new digit to the one immediately prior to it. The participants will be asked to indicate by electronic button press whether the sum of the addition is 13 or not. The duration of the PASAT will be two 12-min tasks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals diagnosed with FM will have pain of \> 3 months and meet the 1990 and 2011 Diagnostic Criteria for FM (ACR) * Healthy, pain-free age and sex matched controls without chronic pain Exclusion Criteria: * Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.). * FM patients must be willing to discontinue or hold their FM related medications for a minimum of one day prior to the visit. * Significant vision loss not corrected by eye wear * Family history of photosensitive epilepsy

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100

FM and control subjects will provide verbal ratings of experimental pain stimuli. For this purpose a numerical ratings scale (0-100) will be used ranging from "no sensation" to the "most intense sensation possible". All measures will be obtained in triplicates and the averages will be used for statistical comparisons.

Time frame: 1 hour

Visual Evoked Potentials (VEP) During Flicker

FM and control subject will focus on a light source while VEPs are obtained. EEG tracings will be evaluated by special software to detect VEP. For intensity ratings of the flicker stimulus a numerical ratings scale (0-100) will be used ranging from "no sensation" to the "most intense sensation possible". All measures will be obtained in triplicates and the averages will be used for statistical comparisons.

Time frame: 1 hour

Secondary Outcomes

Response to 2011 Fibromyalgia Criteria Questionnaire

FM and control subjects will complete the 2011 FM Questionnaire. The answers of this questionnaire will be added to obtain the wide-spread pain index and the somatic symptom score. The scores will be combined to obtain the final score. Scores of \>12 fulfill the Criteria for Fibromyalgia

Time frame: 0.5 hours

Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire

FM and control subjects will complete the CES-D. The answers of this questionnaire will be combined to obtain a final score. Total scores of \>15 are consistent with the diagnosis of major depression.

Time frame: 0.5 hours

Data from ClinicalTrials.gov

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